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Norethindrone and ethinyl estradiol and ferrous fumarate

These highlights do not include all the information needed to use NORETHINDRONE and ETHINYL ESTRADIOL TABLETS (CHEWABLE) and FERROUS FUMARATE TABLETS safely and effectively. See Full Prescribing Information for NORETHINDRONE and ETHINYL ESTRADIOL TABLETS (CHEWABLE) and FERROUS FUMARATE TABLETS. NORETHINDRONE and ETHINYL ESTRADIOL tablets (chewable) and FERROUS FUMARATE tablets, for oral use Initial U.S. Approval: 1975

Approved
Approval ID

1f7a19f1-fd30-4bd2-aab6-926d911d2579

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2023

Manufacturers
FDA

Naari Pte Limited

DUNS: 659345996

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

norethindrone and ethinyl estradiol and ferrous fumarate tablet

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79929-005
Application NumberANDA207066
Product Classification
M
Marketing Category
C73584
G
Generic Name
norethindrone and ethinyl estradiol and ferrous fumarate tablet
Product Specifications
Effective DateFebruary 15, 2023
FDA Product Classification

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Norethindrone and ethinyl estradiol and ferrous fumarate - FDA Drug Approval Details